Effects of Video-based Health Education on Maternal and Child Health in Ethiopia

Anemia Clinical Trial

— MCH  

Official title:

Effects of Video-based Health Education on Health Status of Pregnant Mothers and Their Infants (From 0 to 6 Months) in Dirashe District Southern Ethiopia - a Cluster Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414527
• Other study ID #: BC-06756
• Status: Completed
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low adherence to recommended health and nutrition strategies during the critical 1000 day-window of opportunity is multifactorial but low quality communication is key limitation. Innovative strategies to improve interpersonal communication can reduce the burden and the fatigue of community health workers and may result in a greater change. The findings of this project will support governments and other stakeholders in their delivery of high impact nutrition and health practices.

This intervention aims to improve adherence to ante- and post-natal care practices and recommendations by the use of our video-based health education. These videos will be implemented through home-based counseling by trained assistants, and video-based forum participation led by community nurses and health extension workers (HEWs). During the monthly forums, the educational package will be delivered in a video form - locally prepared using multiple approaches like testimony, comedy, dramas in the form of questions and answers, group discussions and deductive approaches. Cordless projectors and locally created videos give the health community more quality control over the end message, expand the number of people reached, allow for the use of minimally trained non-expert facilitators such as the hews, and allow for contextually appropriate information. They can also be used in areas without access to electricity, helping to bridge the digital divide, and serving as a leapfrog technology for areas that would otherwise not have access to media.

Description:

In Ante- and post-natal care, low adherence to recommended health and nutrition strategies during the critical 1,000 day-window of opportunity is multifactorial, but low-quality communication is key limitation. Innovative strategies to improve interpersonal communication can reduce the burden and the fatigue of community health workers and may result in a greater change. The findings of this project will support governments and other stakeholders in their delivery of high impact nutrition and health practices.

Focused antenatal care (FANC), including iron and folic acid supplementation (IFA) is one of the main strategies to reduce maternal and child deaths. The WHO recommends at least four hospital visits during the pregnancy. Supplementation with IFA during pregnancy improves birth weight and reduces megaloblastic anemia by 79%. The uptake of nutritional and health practices is influenced by complex, contextual determinants at the individual and community levels. Evidence showed that Social and Behavior Change Communication (SBCC) is an effective approach to increase the uptake of key strategies and to sustain behavior change.

Ethiopia, a low-income country in sub-Saharan Africa, has one of the highest maternal and infant mortality rates. It is estimated that 676 mothers die per 100,000 live births and that 59 infants die per 1,000 live births. Maternal anemia is associated with an increased risk of maternal death. Iron deficiency anemia is a strong risk factor for low birthweight (LBW) and perinatal mortality. genital infections such as bacterial vaginosis, candidiasis and worm infections (such as intestinal hookworm infections) are considered important infections that possibly could confound the study results. Bacterial vaginosis and candidiasis are a known risk factor for preterm birth. these infections are also linked with anemia and maternal nutritional status. Hookworm infections are highly prevalent in Ethiopia and are associated with undernutrition and anemia.

The reports of the Ethiopian Demographic and Health Survey showed an increase in women aged 15-49 years in Ethiopia receiving antenatal care (ANC) from a skilled provider up to 62% in 2016 (EDHS, 2016). The percentage of women taking IFA supplements for 90 days or more remains at a substandard level of only 5% (EDHS, 2016). Antenatal care coverage for at least one visit is 28% but coverage for at least four visits declines to 12%, suggesting systemic barriers that potentially prevent the mothers from returning to the health centers. One of the barriers may be perceived failure of the existing interventions to make a meaningful impact that could stimulate the desired behavioral change.

This intervention aims to improve adherence to ante- and post-natal care practices and recommendations by the use of our video-based health education. These videos will be implemented through home-based counseling by trained assistants, and video-based forum participation led by community nurses and Health Extension Workers (HEWs). The nutrition-specific education packages will be based on the WHO-UNICEF key messages booklet on the community, infant and young child feeding counseling package and will be culturally adjusted to fit the local context and translated into the main four local languages. The videos will also include some hygienic aspects that reduce the risk of both genital and parasitic infections, that are also causing undernutrition, anemia and/or adverse pregnancy outcomes. During the monthly forums, the educational package will be delivered in a video form - locally prepared using multiple approaches like testimony, comedy, dramas in the form of questions and answers, group discussions and deductive approaches (more details can be found on OMPT website https://www.ompt.org/).

The main objective of this project is to assess the effects of this innovative video-based health education on reproductive health, and on birth outcomes and the nutritional status of women and their infants from birth to six months of age.

PRIMARY OBJECTIVES

1. To assess the effects of video-based health education package provided to pregnant and lactating women on the knowledge, attitude and practice on recommended health including adherence to ANC visits and to IFA supplementation.

2. To assess the effects of video-based health education on birth outcomes and anemia status of women during pregnancy, at delivery and six-month postpartum.

3. To evaluate the effect of video-based health education on early initiation and exclusive breastfeeding (EBF) of infants from 0-6 months of age In this two-arm cluster randomized trial, 675 pregnant women in their first trimester (12 weeks of gestation) will be recruited and followed up until delivery and then with their infants for six months postpartum.

The intervention will include home to home visit for delivery of healthy nutrition and hygienic messages using prepared video-based messages. participation in monthly forums will be facilitated by nurses using also videos for demonstration of nutritional and hygienic care and will be delivered at the homes of the participants every month by trained HEW until delivery, in addition to the ANC regular visits. During the monthly forums (six in total during the pregnancy and the post-partum periods), the messages will all be given as a video show, coordinated by a nurse/ health professional who will further answer any questions. During the postnatal period, two counseling sessions will be organized within the first two weeks after birth, and a further six sessions ( every month) till 6 months postnatally.

The HEW will distribute the IFA 30 tablets (30 mg elemental iron and 400 µg of folic acid) every month, and will provide counseling on the importance of- and instructions on adherence and other recommendations as detailed earlier. Pregnant women in the control group will receive the standard education package as per the Ethiopian guidelines. In the standard health care, pregnant women receive a minimum of four ANC visits at the health centers during which they also receive IFA supplementation. The control and the intervention groups receive the same amount of tablets (i.e. 30 tablets containing 30 mg elemental iron and 400 µg of folic acid, every month). Monthly IFA utilization will be checked through HEW or our trained service delivery workers during home to home visit. Women who test positive for soil-transmitted helminth will be treated according to the national protocol starting from the second trimester (treatment is not advised during the first trimester). Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.

Data will be collected in pregnant women at baseline, at six and at 9 months of pregnancy . After delivery data will be collected in the pairs mother-infant within two weeks and at 3 and 6 months postpartum. At the different time points, biological samples will be collected to assess the micronutrient status, the presence of inflammations and the presence of genital and parasitic infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent form

• Aged at least 18 years

• Permanent resident of the village of the study intervention/control

• Planned availability during the whole period of the study (12 months)

• Acceptance of the intervention package including home visits for data collection and morbidity follow up.

Exclusion Criteria:

• Severe anemia (hemoglobin <70 g/L),

• Under nutrition (defined as body mass index before pregnancy of <18.5 kg/m2),

• Chronically ill mothers with tuberculosis or other chronic diseases,

• Reported HIV-positive mother.

• Individuals with anatomical deformity will be excluded due to the difficulty of measurement of height.

Related Conditions & MeSH terms

• Anemia
• Antenatal Care
• Bacterial Vaginoses
• Birth Outcomes
• Exclusive Breastfeeding
• Vaginal Diseases
• Vaginosis, Bacterial
• Worm Infection

Intervention

Behavioral:
• Standard counselling
The control cohort will receive national standard counseling during four ante-natal care visits. Women in the control group will receive additionally national nutrition and health care including IFA supplementation, treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters, Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.
• Health-Video
The intervention cohort Health-Video will receive innovative video-based nutritional and hygienic education. Women in this group will receive additionally: National nutrition and health care including IFA supplementation treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters, Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis.

Locations

Country	Name	City	State
Ethiopia	Arba Minch University	Arba Minch	Dirashe District

Sponsors (3)

Lead Sponsor	Collaborator
University Ghent	College of Medicine and Health Sciences, Arba Minch University, Ethiopia, Flemish Interuniversity Council (VLIR)

Country where clinical trial is conducted

Ethiopia, 

References & Publications (10)

Ashorn P, Hallamaa L, Allen LH, Ashorn U, Chandrasiri U, Deitchler M, Doyle R, Harjunmaa U, Jorgensen JM, Kamiza S, Klein N, Maleta K, Nkhoma M, Oaks BM, Poelman B, Rogerson SJ, Stewart CP, Zeilani M, Dewey KG. Co-causation of reduced newborn size by maternal undernutrition, infections, and inflammation. Matern Child Nutr. 2018 Jul;14(3):e12585. doi: 10.1111/mcn.12585. Epub 2018 Jan 8. — View Citation

Asundep NN, Jolly PE, Carson AP, Turpin CA, Zhang K, Wilson NO, Stiles JK, Tameru B. Effect of Malaria and Geohelminth Infection on Birth Outcomes in Kumasi, Ghana. Int J Trop Dis Health. 2014;4(5):582-594. — View Citation

Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: — View Citation

Brooker S, Bethony J, Hotez PJ. Human hookworm infection in the 21st century. Adv Parasitol. 2004;58:197-288. Review. — View Citation

Kavle JA, Landry M. Addressing barriers to maternal nutrition in low- and middle-income countries: A review of the evidence and programme implications. Matern Child Nutr. 2018 Jan;14(1). doi: 10.1111/mcn.12508. Epub 2017 Aug 24. Review. — View Citation

Lassi ZS, Salam RA, Haider BA, Bhutta ZA. Folic acid supplementation during pregnancy for maternal health and pregnancy outcomes. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD006896. doi: 10.1002/14651858.CD006896.pub2. Review. — View Citation

Prociv P, Luke RA. Evidence for larval hypobiosis in Australian strains of Ancylostoma duodenale. Trans R Soc Trop Med Hyg. 1995 Jul-Aug;89(4):379. — View Citation

Rasmussen KM, Stoltzfus RJ. New evidence that iron supplementation during pregnancy improves birth weight: new scientific questions. Am J Clin Nutr. 2003 Oct;78(4):673-4. — View Citation

Tuddenham S, Ghanem KG, Caulfield LE, Rovner AJ, Robinson C, Shivakoti R, Miller R, Burke A, Murphy C, Ravel J, Brotman RM. Associations between dietary micronutrient intake and molecular-Bacterial Vaginosis. Reprod Health. 2019 Oct 22;16(1):151. doi: 10.1186/s12978-019-0814-6. — View Citation

Verstraelen H, Delanghe J, Roelens K, Blot S, Claeys G, Temmerman M. Subclinical iron deficiency is a strong predictor of bacterial vaginosis in early pregnancy. BMC Infect Dis. 2005 Jul 6;5:55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to iron and folic acid supplementation during pregnancy	Monthly disappearance rate of IFA tablets	Monthly during six months pregnancy
Primary	Adherence to iron and folic acid supplementation post-partum	Monthly disappearance rate of IFA tablets	Monthly during three months postpartum
Primary	Maternal anemia during pregnancy	Hemoglobin concentrations (g/dL)	Hemoglobin concentrations will be measured at 9 months pregnancy
Primary	Maternal anemia post-partum	Hemoglobin concentrations (g/dL)	Hemoglobin concentrations will be measured at six months postpartum
Primary	Early initiation	Prevalence of newborns put to the breast in the first hour after birth	At birth (six months after the enrollment)
Primary	Exclusive breastfeeding	Prevalence of infants exclusively breastfed using maternal reports and the deuterium dose-to-mother technique (in a subgroup)	Birth to six months postpartum
Primary	Dietary intake during six months pregnancy	Prevalence of women with adequate dietary intake during six months pregnancy	Assessed at 6 months and 9 months pregnancy
Primary	Dietary intake at six months post-partum	Prevalence of women with adequate dietary intake at six months post-partum	Assessed at six months postpartum
Secondary	Gestational weight gain	Weight gain at term (Kg)	Gestational weight gain will be measured in all pregnant women at six and nine months pregnancy
Secondary	Maternal genital infections	The presence of genital infections that are known to affect a healthy pregnancy, including but not limited to bacterial vaginosis, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Listeria monocytogenes.	Maternal genital infections will be assessed at nine months pregnancy
Secondary	Birth weight	Birth weight (g)	Birth weight will be assessed in all newborns
Secondary	Infant weight	Infant weight (g) on a monthly basis	Weight of infants will be assessed monthly from birth until six months of age
Secondary	Infant length	Infant length (cm) on a monthly basis	Length of infants will be assessed monthly from birth until six months of age
Secondary	Infant anemia	Hemoglobin concentrations (g/dL)	Hemoglobin concentrations will be measured at six months of age
Secondary	Maternal parasitic infections	The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms).	Worm infections will be assessed in all women at 6 months pregnancy, 9 months pregnancy, and at two weeks- and 6 months post partum
Secondary	Infant parasitic infections	The prevalence of Giarida and Cryposporidium will be assessed in all infants	Infant parasitic infections will be assessed at 6 months of age.
Secondary	Maternal plasma ferritin	Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores	Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Secondary	Infant plasma ferritin	Iron status as indicated plasma ferritin (micro_g/L) is a test to evaluate iron stores	Plasma ferritin is assessed in a subgroup of infants at six months of age
Secondary	Maternal soluble transferrin receptor	Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings	Plasma ferritin is assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Secondary	Infant soluble transferrin receptor	Soluble transferrin receptor (mg/L) is an indicator for iron deficiency especially in high inflammation settings	Soluble transferrin receptor is assessed in a subgroup of infants at six months of age
Secondary	Maternal serum concentrations in Vitamin A (retinol)	Retinol concentrations in serum is an indicator of vitamin A status	Serum concentrations in Vitamin A are assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Secondary	Infant serum concentrations in Vitamin A (retinol)	Retinol concentrations in serum is an indicator of vitamin A status	Serum concentrations in Vitamin A are assessed in a subgroup of infants at six months of age
Secondary	Maternal serum concentrations in vitamin B12	Serum concentrations in vitamin B12	Vitamin B12 concentrations will be assessed in a subgroup of women at 9 months pregnancy and at six months postpartum
Secondary	Infant serum concentrations in vitamin B12	Serum concentrations in vitamin B12	Vitamin B12 concentrations will be assessed in a subgroup of infants at six months of age

External Links

•   Evidence of Effective Approaches to Social and Behavior Change Communication for Preventing and Reducing Stunting and Anemia: Report from a Systematic Literature Review
•   Review of Incorporation of Essential Nutrition Actions in Public Health Programs in Ethiopia. Washington, DC: Food and Nutrition Technical Assistance Project (FANTA)